None listed
Conditions
Brief summary
Aim: To determine in a proof-of-concept study if re-purposing existing approved medications that target the sleep/wake system and upper airway muscle control reduce sleep apnoea severity. Research design: randomised, double -blind, placebo-controlled, cross-over. Methods: Participants will be required to attend 2 overnight visits, each separated by 1 week in the sleep laboratory. Standard sleep monitoring equipment will be applied including: electrodes on the surface of the head, face and chest to monitor wakefulness and sleep, a sensor placed on the finger to monitor oxygen levels, bands placed around the chest and abdomen along with airflow sensors or a mask over the nose to monitor breathing. Participants will be randomised to receive either a placebo (sugar pill) or a combination of two medications (betahistine 96 mg + oxybutynin 5 mg) just prior to sleep.
Interventions
Randomised, placebo-controlled, two arm crossover study (~1 week washout between visits): Arm 1: oral capsules of betahistine (96 mg) and oxybutynin (5mg) immediately prior to sleep (single night, in laboratory study)
Arm 2: placebo oral capsules immediately prior to sleep (single night, in-laboratory study)
Interventions will be administered by a study investigator on each laboratory visit just prior to sleep for these acute sleep studies to ensure adherence.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Otherwise healthy adults with obstructive sleep apnoea aged 18 - 75 years with BMI < 40.0kg/m^2 at screening.
Exclusion criteria
• Any acute or chronic medical condition other than well controlled hypertension , hyperlipidemia, compensated diabetes. • Any medication known to influence breathing, sleep/arousal or muscle physiology. • Any medication known to interact with mono amino oxidases. • Inability to sleep supine (data collection requires a majority of supine position and body position is controlled) • Any other condition which in the opinion of the investigator would present an unreasonable risk to the participant, or which would interfere with their participation in the study or unduly confound study interpretation, or would render the participant unable or unlikely to understand or comply with the study design, or the receive the specified medications. • Allergy to oxymetazoline HCl, betahistine dihydrochloride, oxybutynin hydrochloride. • Bronchial asthma and atopic family history, which are more susceptible to associate with bronchospasm following betahistine dihydrochloride administration. • Gastric or peptic ulcer, which might be worsened by betahistine dihydrochloride administration on an empty stomach. • Benign prostatic hyperplasia or urinary retention, which can be exacerbated by the antimuscarinic agent. • Individuals with underlying cardiac disease, such as arrhythmias. • Individuals with previous or recent history of phaeochromocytoma. • Individuals taking tricyclic antidepressants. • History of moderate or severe renal impairment. • Pregnancy or breast feeding.
Outcome results
None listed